510(k) Report

Devices descending from K120979

12 later devices reach Carefusion Nicolet Edx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243982Nicolet EDXNatus Neurology Incorporated20250—
+1K172743Natus VikingQuestNatus Neurology Incorporated20170—
+1K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+1K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+2K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+2K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+2K230415Cadwell GuardianCadwell Industries, Inc.20230—
+2K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+2K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+3K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+3K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302